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Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy
NCT05747794 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy? * Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone? In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled). The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
Conditions Studied
Interventions
- DRUG Paclitaxel
- OTHER placebo
- BIOLOGICAL eftilagimod alpha
Study Locations (20)
Other
- AZ Sint-Jan Brugge Oostende av — Bruges
- Cliniques Universitaires Saint-Luc — Brussels
- Grand Hopital de Charleroi - Hopital Notre Dame — Charleroi
- Universitair Ziekenhuizen Antwerpen — Edegem
- Centre Hospitalier de l'Ardenne — Libramont
- Clinique Saint-Pierre- Ottignies — Ottignies-Louvain-la-Neuve
- ARENSIA Exploratory Medicine LLC — Tbilisi
- ARENSIA Exploratory Medicine Phase I Unit — Chisinau
- Institut Català d'Oncologia — Badalona
- VHIO - Hospital Vall d'Hebron — Barcelona
- Hospital Clinic de Barcelona — Barcelona
- Parc Taulí Hospital Universitari — Barcelona
- Hospital Universitario Reina Sofia — Córdoba
- Hospital Universitario de Jaén — Jaén
- Unidad Ensayos Clínicos Oncología Fundació IRB Lleida — Lleida
Texas
- Oncology Consultants — Houston
- The University of Texas MD Anderson Cancer Center — Houston
California
- The Oncology Institute — Whittier
District of Columbia
- The George Washington University Cancer Center — Washington D.C.
South Carolina
- Carolina Blood and Cancer Care Associates — Rock Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 849 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05747794
The ClinicalTrials.gov registry entry for NCT05747794 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 849 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immutep S.A.S., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Paclitaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05747794 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05747794 about?
NCT05747794 is a clinical study titled "Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination with Paclitaxel Chemotherapy". The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of eft...
What is the current status of trial NCT05747794?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 849 participants. The study started on 2023-05-22. Estimated completion is 2027-07-31.
What conditions does trial NCT05747794 study?
This clinical trial studies the following conditions: Breast Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05747794?
The interventions under investigation include: Paclitaxel (DRUG), placebo (OTHER), eftilagimod alpha (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05747794?
This trial is sponsored by Immutep S.A.S., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05747794 being conducted?
This trial has 20 study locations across California, District of Columbia, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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